Uveal MelanomaPhase 3NCT01983748
Dendritic Cells Plus Autologous Tumor RNA in Uveal Melanoma
A Phase 3 study testing Autologous Dendritic Cells loaded with autologous Tumor RNA in people with Uveal Melanoma, run by University Hospital Erlangen at 8 sites in Germany.
Trial summary
Patients suffering from uveal melanoma (typed positive for monosomy 3 and without evidence for metastases) will be vaccinated over a period of 2 years with Dendritic Cell loaded with autologous Tumor RNA. 200 patients will be included. The Trial is an open multicenter Phase III Trial. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- Autologous Dendritic Cells loaded with autologous Tumor RNA
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 8 sitesGermany
- Study dates
- 5 Aug 2014to 3 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must suffer from melanoma of the uvea (stage T2, T3 and T4 [AJCC TNM grading 2009]).
- Uveal melanoma must be resected and display a monosomy for chromosome 3 (will be determined by a validated qualitative analysis of loss of heterozygosity). Tumor material has to be stored appropriately in RNAlater solution for RNA preparation.
- The patient has to be free of detectable tumor at the time point of study enrollment (adjuvant setting), as assessed by clinical inspection, abdominal sonography, chest X-ray and evaluation of the tumor-marker S-100..
- Patients must have a WHO performance status of 0, 1 or 2 and must be in stable medical condition.
- Patients must be between 18 and 75 years old and must be able and willing to give informed consent.
- Women of child-bearing age must have a negative pregnancy test, and must oblige to use effective contraception until at least 4 weeks after the last vaccination.
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- Patients must be willing to get hospitalized for at least 4 hours following vaccination(s), and to cooperate for the whole period of the trial.
- Patients must have fully recovered from surgery.
- Signed informed consent
Who cannot join
- Any other major serious illness [e.g. active systemic infections, immunodeficiency disease, clinically significant heart disease, respiratory disease, bleeding disorders, cancer etc.] or a contraindication to leukapheresis.
- Evidence for HIV-1, HIV -2, HTLV-1, HBV, or HCV infection.
- Active autoimmune disease (such as but not limited to Lupus erythematosus, autoimmune thyroiditis or uveitis, multiple sclerosis, inflammatory bowel disease). Vitiligo and pathological laboratory results (autoantibodies) without clinical symptoms are, however, not an exclusion criterion.
- Previous splenectomy or radiation therapy to the spleen.
- Patients with organ allografts.
- Concomitant treatment with chemotherapy, immunotherapy, any investigational drug and paramedical substances. Patients may receive concomitant medications to control symptoms such as analgetics, antihypertensive medication, etc.
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- History of other active malignant neoplasm within the preceding 5 years (excluding non-melanoma skin cancer or carcinoma in situ of the cervix).
- Organic brain syndrome or significant psychiatric abnormality which would impede informed consent and / or AND preclude participation in the full protocol and follow up.
- Positive pregnancy test / Pregnancy or lactation. If pregnancy occurs during the course of the trial to female patients in arm A or B, the patient has to be excluded.
- Detection of metastases. If uveal melanoma metastases appear during the course of the trial, the patient has to be excluded.
- Lack of compliance of the patient.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Städtisches Klinikum
Dessau, 06847
Dept. of Dermatology, University Hospital
Erlangen, Bavaria, 90154
University Hospital Department of Ophtalmology
Erlangen, Bavaria, 91054
University Hospital Department of Ophtalmology
Essen, 45122
University Hospital Department of Ophtalmology
Homburg/Saar, 66421
University Hospital Department of Ophtalmology
Lübeck, 23538
University Hospital Department of Ophtalmology
Tübingen, 72076
University Hospital Department of Ophtalmology
Würzburg, Bavaria, 97080
About this study
Official title: A NON-COMMERCIAL, MULTICENTER, RANDOMIZED, TWO-ARMED, OPEN-LABEL PHASE III STUDY TO EVALUATE THE ADJUVANT VACCINATION WITH TUMOR RNA-LOADED AUTOLOGOUS DENDRITIC CELLS VERSUS OBSERVATION OF PATIENTS WITH RESECTED MONOSOMY 3 UVEAL MELANOMA
Patients suffering from uveal melanoma (typed positive for monosomy 3 and without evidence for metastases) will be vaccinated over a period of 2 years with Dendritic Cell loaded with autologous Tumor RNA.
200 patients will be included. The Trial is an open multicenter Phase III Trial.
Read the detailed description
Trial arm A (DCaT-RNA) = Experimental intervention: Patients in arm A receive 8 vaccinations over a period of 2 years consisting of autologous, mature, monocyte-derived Dendritic Cells loaded with autologous tumor RNA (20 mio DC per vaccination); cells are given via intravenous infusions; vaccinations are followed by a 1 year observation (staging every 3 months)
Trial arm B (Observation) = Control: Patients in arm B receive standard care (observation only with staging every 3 months)
- Conditions
- Uveal Melanoma
- Being tested
- Autologous Dendritic Cells loaded with autologous Tumor RNA
- Keywords
- Uveal Melanoma, Monosomy 3
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Dendritic Cells loaded with autologous Tumor RNABiological
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Biological/Vaccine; Autologous Dendritic Cells loaded with autologous Tumor RNA Receives: Biological: Autologous Dendritic Cells loaded with autologous Tumor RNA |
| B | No intervention | Control, Standard of care, which is clinical control every 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolongation of Overall survival
Clinical staging every 3 months from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months, followed by telephone interviews.
Measured: Assessment every 3 months
Secondary outcomes (1)
Prolongation of disease free survival
Skin, lymph node and ophtalmological inspection , medical history, laboratory, and abdominal sonography will be performed every 3 months, chest x ray will be performed every 6 months
Measured: Assessment every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study start5 Aug 2014
- Primary completion31 Aug 2024
- Study completion3 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Erlangen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Lübeck, University Hospital Munich, Universitätsklinikum Hamburg-Eppendorf, University Hospital Homburg/Saar, Universitätsklinikum Köln, University Hospital Tuebingen, University Hospital, Essen, Wuerzburg University Hospital
- Responsible party
- Principal investigator, PD Dr. med. univ. Beatrice Schuler-Thurner, University Hospital Erlangen
- Investigators
- Beatrice Schuler-Thurner, MD, Principal investigator, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983748
- Sponsor's protocol ID
- DERMA-ER-DC 08
- Status last verified
- Mar 2025
- First submitted
- 17 Sep 2013
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schuler-Thurner B, Bartz-Schmidt KU, Bornfeld N, Cursiefen C, Fuisting B, Grisanti S, Heindl LM, Holbach L, Keseru M, Knorr H, Koch K, Kruse F, Meiller R, Metz C, Meyer-ter-Vehn T, Much M, Reinsberg M, Schliep S, Seitz B, Schuler G, Susskind D, Viestenz A, Wagenfeld L, Zeschnigk M. [Immunotherapy of uveal melanoma: vaccination against cancer. Multicenter adjuvant phase 3 vaccination study using dendritic cells laden with tumor RNA for large newly diagnosed uveal melanoma]. Ophthalmologe. 2015 Dec;112(12):1017-21. doi: 10.1007/s00347-015-0162-z. German.
PubMed 26602097
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A NON-COMMERCIAL, MULTICENTER, RANDOMIZED, TWO-ARMED, OPEN-LABEL PHASE III STUDY TO EVALUATE THE ADJUVANT VACCINATION WITH TUMOR RNA-LOADED AUTOLOGOUS DENDRITIC CELLS VERSUS OBSERVATION OF PATIENTS WITH RESECTED MONOSOMY 3 UVEAL MELANOMA
- ClinicalTrials.gov ID
- NCT01983748
- Acronym / sponsor ID
- DERMA-ER-DC 08
- Conditions
- Uveal Melanoma
- Keywords
- Uveal Melanoma, Monosomy 3
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital ErlangenUniversity, hospital or other
- Collaborators
- University Hospital Lübeck, University Hospital Munich, Universitätsklinikum Hamburg-Eppendorf, University Hospital Homburg/Saar, Universitätsklinikum Köln, University Hospital Tuebingen, University Hospital, Essen, Wuerzburg University Hospital
- Study start
- 5 Aug 2014 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 14 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients suffering from uveal melanoma (typed positive for monosomy 3 and without evidence for metastases) will be vaccinated over a period of 2 years with Dendritic Cell loaded with autologous Tumor RNA.
200 patients will be included. The Trial is an open multicenter Phase III Trial.
Detailed description
Trial arm A (DCaT-RNA) = Experimental intervention: Patients in arm A receive 8 vaccinations over a period of 2 years consisting of autologous, mature, monocyte-derived Dendritic Cells loaded with autologous tumor RNA (20 mio DC per vaccination); cells are given via intravenous infusions; vaccinations are followed by a 1 year observation (staging every 3 months)
Trial arm B (Observation) = Control: Patients in arm B receive standard care (observation only with staging every 3 months)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: Autologous Dendritic Cells loaded with autologous Tumor RNABiological/Vaccine; Autologous Dendritic Cells loaded with autologous Tumor RNA |
| B | No intervention | –Control, Standard of care, which is clinical control every 3 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must suffer from melanoma of the uvea (stage T2, T3 and T4 [AJCC TNM grading 2009]).
- Uveal melanoma must be resected and display a monosomy for chromosome 3 (will be determined by a validated qualitative analysis of loss of heterozygosity). Tumor material has to be stored appropriately in RNAlater solution for RNA preparation.
- The patient has to be free of detectable tumor at the time point of study enrollment (adjuvant setting), as assessed by clinical inspection, abdominal sonography, chest X-ray and evaluation of the tumor-marker S-100..
- Patients must have a WHO performance status of 0, 1 or 2 and must be in stable medical condition.
- Patients must be between 18 and 75 years old and must be able and willing to give informed consent.
Key exclusion criteria (11 listed)
- Any other major serious illness [e.g. active systemic infections, immunodeficiency disease, clinically significant heart disease, respiratory disease, bleeding disorders, cancer etc.] or a contraindication to leukapheresis.
- Evidence for HIV-1, HIV -2, HTLV-1, HBV, or HCV infection.
- Active autoimmune disease (such as but not limited to Lupus erythematosus, autoimmune thyroiditis or uveitis, multiple sclerosis, inflammatory bowel disease). Vitiligo and pathological laboratory results (autoantibodies) without clinical symptoms are, however, not an exclusion criterion.
- Previous splenectomy or radiation therapy to the spleen.
- Patients with organ allografts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Dendritic Cells loaded with autologous Tumor RNA | Biological | A |
Primary outcome
Prolongation of Overall survival
Time frame: Assessment every 3 months
Clinical staging every 3 months from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months, followed by telephone interviews.
1 secondary outcome
Prolongation of disease free survival
Time frame: Assessment every 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Background: PubMed 26602097Schuler-Thurner B, Bartz-Schmidt KU, Bornfeld N, Cursiefen C, Fuisting B, Grisanti S, Heindl LM, Holbach L, Keseru M, Knorr H, Koch K, Kruse F, Meiller R, Metz C, Meyer-ter-Vehn T, Much M, Reinsberg M, Schliep S, Seitz B, Schuler G, Susskind D, Viestenz A, Wagenfeld L, Zeschnigk M. [Immunotherapy of uveal melanoma: vaccination against cancer. Multicenter adjuvant phase 3 vaccination study using dendritic cells laden with tumor RNA for large newly diagnosed uveal melanoma]. Ophthalmologe. 2015 Dec;112(12):1017-21. doi: 10.1007/s00347-015-0162-z. German.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatrice Schuler-Thurner, MD principal investigator
University Hospital Erlangen
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Autologous Dendritic Cells loaded with autologous Tumor RNA in people with Uveal Melanoma, run by University Hospital Erlangen at 8 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolongation of Overall survival (time frame: Assessment every 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01983748, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.